Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-13

Study Completion Date

2019-07-31

Brief Summary

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The purpose of this study was to investigate the effects of the combination treatment strategy. A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset \> 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

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Detailed Description

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Background and objectives: Previous studies have shown that transcranial direct current stimulation (tDCS) and Neuromuscular electrical stimulation (NMES) could be effective for promoting motor recovery of stroke patients. However, the effects of tDCS combined with NMES on upper extremity (UE) motor recovery in patients with stroke have not been investigated. The purpose of this study was to investigate the effects of the combination treatment strategy. Methods: A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset \> 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. Results: Most of the participants had mild to moderate disability in activity of daily living. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. Conclusion: This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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tDCS combined with NMES

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

Group Type EXPERIMENTAL

tDCS(Intelect Mobile Stimulation and Combination, DJO, France)

Intervention Type COMBINATION_PRODUCT

NMES(Enraf Nonius, Endomed-182, Netherlands)

Intervention Type COMBINATION_PRODUCT

tDCS combined with sham NMES

In addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

Group Type ACTIVE_COMPARATOR

tDCS(Intelect Mobile Stimulation and Combination, DJO, France)

Intervention Type COMBINATION_PRODUCT

NMES(Enraf Nonius, Endomed-182, Netherlands)

Intervention Type COMBINATION_PRODUCT

sham tDCS combined with sham NMES

In addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).

Group Type SHAM_COMPARATOR